21 CFR § 211.111 - Time limitations on production.

---
identifier: "/us/cfr/t21/s211.111"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 211.111 - Time limitations on production."
title_number: 21
title_name: "Food and Drugs"
section_number: "211.111"
section_name: "Time limitations on production."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "211"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264."
regulatory_source: "43 FR 45077, Sept. 29, 1978, unless otherwise noted."
cfr_part: "211"
---


# 211.111 Time limitations on production.

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.